MAUDE Adverse Event Report: ZIMMER, INC. CABLE-READY CABLE GRIP TENSIONER; TRAUMA INSTRUMENT

Catalog Number 00223200500

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same event (reference 1822565-2016-04805).

Event Description

It is reported that the tensioners' knobs were not able to be moved when examined during kit inspection prior to hospital delivery.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.No devices or photos were returned for evaluation.The device history records were reviewed for both the tensioners with no deviations or anomalies being identified.This device is used for treatment.The complaint history review was conducted for the devices and found no additional complaints for the same lots.Surgical technique and notes were not provided.A definitive root cause of the reported issue cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The tensioners were received for evaluation.The items were tested by assembling them with their mating components with torque being applied at the high end of normal operating range.Both tensioners operated correctly along with the levers and buttons working as intended.The device history records were reviewed and no deviations or anomalies were identified.This device is used for treatment.The complaint history reviews were conducted for the devices and found no additional complaints for the same lots.A definitive root cause of the reported issue cannot be determined with the information provided.The reported issue could not be confirmed, as the devices functioned as intended.Another mdr report was filed for this event, please see associated report: 0001822565 - 2016 - 04805-2.

• Brand Name: CABLE-READY CABLE GRIP TENSIONER
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6210340
• MDR Text Key: 63427745
• Report Number: 0001822565-2016-04804
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK151907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00223200500
• Device Lot Number: 62469251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1